RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence
Research type
Research Study
Full title
RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence-based psychosocial interventions
IRAS ID
258527
Contact name
Ross White
Contact email
Sponsor organisation
University of Verona
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
3198, University of Liverpool Central Ethics Committee
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
RE-DEFINE aims to implement effective psychological interventions for preventing the onset of mental disorders in refugees and asylum seekers with psychological distress resettled in middle-income and high-income countries. RE-DEFINE is particularly relevant for the refugee crisis in Europe and in bordering countries (i.e., Turkey), as the progressive increase in people seeking asylum poses a significant challenge to the health systems’ capacity to adequately respond to the health needs of this population.
The project focuses on the adaptation, testing, and implementation of Self Help Plus (SH+), a novel trans-diagnostic self-help preventive psychosocial intervention specifically developed by the World Health Organization (WHO) to respond to humanitarian crises. The research will aim to recruit 600 refugees and asylum seekers across collaborating sites in: UK, Italy, Germany, Austria and Finland. The project is running for 3 years from 1st January 2018 to 31st December 2020.
In Glasgow/West of Scotland, the project will be aiming to recruit 100 participants (50 randomsied to the SH+ intervention and 50 control participants.
The Self-help Plus (SH+) intervention that will be evaluated is aimed at preventing refugees and asylum seekers from developing common mental disorders (e.g. major depressive disorder and anxiety disorders). Participants giving consent to participate will be initially assessed using the General Health Questionnaire (GHQ-12) in order to select a population with clinically significant psychological distress (i.e. GHQ score > 3). As a second step, those with a GHQ > 3 will be assessed for the presence of a mental disorder by means of the Mini Neuropsychiatric Interview (MINI). Only refugees and asylum seekers with psychological distress and no mental disorders will be included in the trial. These participants will be randomly allocated in a 1:1 ratio to receive SH+ or enhanced care as usual. Participants will be assessed at baseline, at 6-weeks post-baseline, 6-months post-baseline and 12-months post-baseline.REC name
North of Scotland Research Ethics Committee 2
REC reference
19/NS/0108
Date of REC Opinion
21 Jun 2019
REC opinion
Further Information Favourable Opinion